Memantine Hydrochloride

ANDA 205784, held by Ph Health. Memantine Hydrochloride.

As of Nov 15, 2026, ANDA 205784 (Memantine Hydrochloride), held by Ph Health, was first approved by FDA on Jun 9, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 9, 2017
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 9, 2017	Original application	Approved	None posted

Products

4 strengths and forms


Memantine Hydrochloride7MG · capsule, extended release;oral	Memantine Hydrochloride	Discontinued
Memantine Hydrochloride14MG · capsule, extended release;oral	Memantine Hydrochloride	Discontinued
Memantine Hydrochloride21MG · capsule, extended release;oral	Memantine Hydrochloride	Discontinued
Memantine Hydrochloride28MG · capsule, extended release;oral	Memantine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jan 27, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Jun 9, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 205784
Drugs@FDA: Overview at FDA
Company: PH Health

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters